Lactoferrin Use in ICU Patients (NCT05936528) | Clinical Trial Compass
CompletedPhase 4
Lactoferrin Use in ICU Patients
Egypt660 participantsStarted 2025-09-29
Plain-language summary
Introduction:
Lactoferrin has several uses due to its effects. It has anti-inflammatory, antioxidant, immunomodulatory, antibacterial, antifungal, and antiviral effects. Its safety is proven by food and drug administration.
Aims:
The objective is to study the effect of lactoferrin on improving clinical outcomes in ICU patients compared to control and standard therapy, and also to evaluate its safety.
Patients and populations:
A sample of 660 patients (330 patients in both groups A, and B) who will be admitted to ICU departments in Mansoura university hospital will be used to represent the population in ICU.
Methods:
A sample of 660 participants was randomized 1:1 into two groups (group A (330 patients), and group B (330 patients)).
This study is a single blind, randomized controlled clinical trial. Randomization was performed by independent clinical pharmacists working in hospital ICU departments.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The inclusion criteria for patients to participate in this research include adult (age ≥ 18 years) patients admitted to ICU for any reason or disease.
Exclusion Criteria:
* inability to give informed consent by patients or their relative,
* history of hypersensitivity to milk products,
* history of lactoferrin use in the past 6 months,
* patients with lactose intolerance,
* patients with no enteral access to administer LF either orally or by Ryle tube,
* patients who are expected to die within 48 hours, and
* patients with poor oral absorption as in case of shock and resected bowel.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
28-days mortality rate
Timeframe: 28 days
2
Number of Participants With any allergic or hypersensitivity reactions